A Prospective, Open Label Study Evaluating Two Management Strategies on Gastrointestinal Symptoms in Patients Newly on Treatment With Pradaxa for the Prevention of Stroke and Systemic Embolism With Non-valvular Atrial Fibrillation

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Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

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Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

This is a Prospective, randomized, open label trial. 1067 patients treated with Pradaxa and 117 patients were randomized to a management strategy. NVAF= non-valvular atrial fibrillation and GIS = gastrointestinal symptoms.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Entered Set (ES): This patient set included all patients entered in the study. For those patients who were randomized to management strategies, their data prior to randomization was included in the entered set. All data from patients who were never randomized are in the entered set.

Limitations of the study, such as early termination leading to small numbers of participants
analyzed and technical problems with measurement leading to unreliable or uninterpretable data

The modest sample size,non-specific nature of symptoms,&reliance on patient self-reporting of their symptoms may contributed some bias to the final result.An open-label design may lead to patient/investigator bias in reporting symptoms.

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is less than or equal to 60 days.
The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is more than 60 days but less than
or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Restriction Description:
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.